At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 684 enrolled
Drug / intervention
Rotarix ™ +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Immunogenicity, Reactogenicity and Safety Study to Evaluate Two Doses of the Lyophilised Formulation of the Human Rotavirus (HRV) Vaccine When Administered to Healthy Korean Infants Previously Uninfected With HRV
In Brief
A Phase 4 clinical trial evaluating Rotarix ™ and Placebo for Infections, Rotavirus and Rotavirus Vaccines. Completed, enrolled 684 participants across 18 sites.
Detailed Summary
The aim of this study is to assess the immunogenicity, reactogenicity and safety of the human rotavirus (HRV) Rotarix ™ vaccine when administered in healthy infants aged approximately 6-12 weeks at the time of first vaccination.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfections, Rotavirus, Rotavirus Vaccines
CountriesSouth Korea
Collaborators--
Timeline
Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2009
First PostedSep 2009
Primary CompletionJul 2010
TodayJul 2026
First PostedSep 1, 2009
Enrollment StartAug 25, 2009
Primary CompletionJul 23, 2010
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.8 years ago
Interventions
Rotarix ™biological
Two oral doses
Placebobiological
Two oral doses